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NCT07301164
Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases
EARLY_PHASE1 trial testing BCT301 in System Lupus Erythematosus in 10 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Peking University Third Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 11 December 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
Drugs / interventions tested
- BCT301 — full drug profile →
Conditions studied
- System Lupus Erythematosus — all drugs for System Lupus Erythematosus →
- Systemic Sclerosis (SSc) — all drugs for Systemic Sclerosis (SSc) →
- Inflammatory Myositis — all drugs for Inflammatory Myositis →
- Antiphospholipid Syndrome — all drugs for Antiphospholipid Syndrome →
Sponsor
Peking University Third Hospital
Who can join
Adults 18 to 80, any sex, with System Lupus Erythematosus or Systemic Sclerosis (SSc). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07301164
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07301164 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University Third Hospital
- Last refreshed: 24 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07301164.
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